K233249 is an FDA 510(k) clearance for the APPRAISE-HRI. This device is classified as a Adjunctive Hemodynamic Indicator With Decision Point For Military Use (Class II - Special Controls, product code SAR).
Submitted by The Surgeon General, Department of the Army (TSG-DA) (Fort Dietrick, US). The FDA issued a Cleared decision on April 5, 2024, 190 days after receiving the submission on September 28, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2220. An Adjunctive Hemodynamic Indicator With Decision Point Is A Device That Identifies And Monitors Hemodynamic Condition(s) Of Interest And Provides Notifications At A Clinically Meaningful Decision Point. This Device Is Intended To Be Used Adjunctively Along With Other Monitoring And Patient Information. The Device Is Intended For Use By The Military..
| 510(k) Number | K233249 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2023 |
| Decision Date | April 05, 2024 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | SAR - Adjunctive Hemodynamic Indicator With Decision Point For Military Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2220 |
| Definition | An Adjunctive Hemodynamic Indicator With Decision Point Is A Device That Identifies And Monitors Hemodynamic Condition(s) Of Interest And Provides Notifications At A Clinically Meaningful Decision Point. This Device Is Intended To Be Used Adjunctively Along With Other Monitoring And Patient Information. The Device Is Intended For Use By The Military. |